Several clinical trials are evaluating amikacin for indications such as multidrug-resistant tuberculosis, febrile neutropenia in hematological patients, nosocomial infections secondary to COVID-19, and asymptomatic decolonization. Spanning Phase 2, Phase 4, and unclassified protocols, these studies range in status from recruiting to active not recruiting and completed. Research is sponsored by university hospitals, non-profit foundations, and international agencies, including the World Health Organization, with specific focus on regimen supplementation and therapeutic target attainment.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05555303 | Recruiting | Tuberculosis Multidrug-Resistant |
Rwanda Biomedical Centre|Institute of Tropical Medicine|World Health Organization |
2023-03-01 | Phase 2 |
| NCT05689450 | Completed | Febrile Neutropenia (FN) |
University Hospital Basel Switzerland |
2022-12-21 | -- |
| NCT05593601 | Recruiting | Colonization Asymptomatic |
Mahidol University |
2022-11-24 | Phase 4 |
| NCT05511129 | Active not recruiting | COVID-19|Nosocomial Infection |
Fondation Hôpital Saint-Joseph |
2022-05-12 | -- |
| NCT04239326 | Completed | Tuberculosis Multidrug-Resistant |
Foundation for Innovative New Diagnostics Switzerland |
2021-04-16 | -- |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).